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Clinical Trials in France / NCT05866835
Recruiting Not applicable

Validation of a Digitalised Intraoral Protection

NCT05866835 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Bordeaux
Phase
Not applicable
Started
2023-10-10
Last updated
2025-08-08

Condition(s) studied

Ventilatory Performances of Athletes During the Use of the Intra-oral Protections

Investigational drug(s) / intervention(s)

Manufacture of custom-made IOPVentilation testsEvaluation of comfort level:

Manufacture of custom-made IOP: Manufacture of custom-made "unimaxillary" and "modified unimaxillary" intra-oral protection (IOP) with vertical dimensions of 4 mm and 6 mm. 3D modeling of a IOP based on: * digital recording of the maxillary and mandibular dental arches * mandibular wedging performed with an inter-arch piece * digital recording of the inter-arch position

Ventilation tests: Realization of a ventilation test (VO2max) to determine the Maximum Aerobic Speed (MAS). Measurement of ventilatory parameters without IOP and with each IOP : * At rest, standing still. * During a 4 minute run on a treadmill at 50% of MAS. * During a 4-minute run on a treadmill, at a speed corresponding to 70% of MAS

Evaluation of comfort level:: Collection from participants (self-questionnaire)

Study summary

Type III (custom-made) intra-oral protection (IOP) models represent 13% of IOP worn by amateur rugby club players in France.

However, this model is recognized as the most effective when made in accordance with essential health and safety requirements.

This observation is at the origin of a new approach that the investigators are proposing with the objective of removing the barriers to access to custom-made IOP. This research is based on the combination of new digital technologies, scanning and 3D printing, to develop a new generation of IOP.

This project aims to show the interest of this new generation of "modified unimaxillary" IOP on the ventilation of the athletes and his/her comfort when he/she evolves with his IOP in place

Eligibility

Sex
ALL
Min age
16 Years
Max age
35 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Subjects between the ages of 16 and 35, * Subject affiliated to a social security system, * Subject affiliated with the French Federation of Boxing or Rugby or Football * Subject having signed a consent form * For minors, legal guardians having signed the free and informed consent form Exclusion Criteria: * Subject with a pathology incompatible with the realization of the trial: * Absolute contraindications: Recent infarction (wait 5 to 12 days depending on severity), Threat syndrome (lawful test after stabilization - at least 3 days without spontaneous seizures), Resting BP \> 200/120 mmHg, Uncompensated heart failure, Third-degree Atrioventricular block, Myocarditis, Pericarditis, Endocarditis, Aortic Dissection, Intracardiac tumor or thrombus, Deep venous thrombosis, Pulmonary Embolism, * Relative contraindications: Aortic stenosis (formal contraindication if lipothymia, syncope or signs of heart failure), Severe non-revascularized coronary artery disease, Pulmonary arterial hypertension (formal contraindication if primary), Severe rapid ventricular or supraventricular arrhythmias * Subject under B-mimetic drug treatment, * Subject with decaying teeth, * Subject under court protection, * Subject participating in another research study, * Subject in pregnancy.

Primary outcome measure(s)

  • Ventilatory flow per minute — 3 weeks (W3) after inclusion (W0)
    The ventilatory flow rate per minute will be measured during the ventilation test

Trial sites (3)

FacilityCityRegionStatus
CHU de Bordeaux Bordeaux France Not Yet Recruiting
CREPS de Bordeaux Bordeaux France Recruiting
Institut national du sport, de l'expertise et de la performance (INSEP) Paris France Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05866835 on ClinicalTrials.gov ↗ ← All trials in France